title: Fluid lavage of open wounds (FLOW): a multicenter, blinded, factorial pilot trial comparing alternative irrigating solutions and pressures in patients with open fractures.
abstract: BACKGROUND
  Open fractures are an important source of morbidity and are associated with delayed union, nonunion, and infection. Preventing infection through meticulous irrigation and debridement is an important goal in management, and different lavage fluids and irrigation techniques (e.g., high- or low-pressure lavage) have been described for this purpose. However, there are a limited number of randomized trials comparing irrigating solutions or irrigating technique. We compared the use of castile soap versus normal saline and high- versus low-pressure pulsatile lavage on the rates of reoperations and complications in patients with open fracture wounds.
  
  
  METHODS
  We conducted a multicenter, blinded, randomized 2 × 2 factorial pilot trial of 111 patients in whom an open fracture wound was treated with either castile soap solution or normal saline and either high- or low-pressure pulsatile lavage. The primary composite outcome of reoperation, measured at 12 months after initial operative procedure, included infection, wound healing problems, and nonunion. Planned reoperations were not included. Secondary outcomes included all infection, all wound healing problems, and nonunion as well as functional outcomes scores (EuroQol-5 dimensions and short form-12).
  
  
  RESULTS
  Eighty-nine patients completed the 1-year follow-up. Among all patients, 13 (23%) in the castile soap group and 13 (24%) in the saline group had a primary outcome event (hazard ratio, 0.91, 95% confidence interval: 0.42-2.00, p = 0.52). Sixteen patients (28%) in the high-pressure group and 10 patients (19%) in the low-pressure group had a primary outcome event (hazard ratio 0.55, 95% confidence interval: 0.24-1.27, p = 0.17). Functional outcome scores showed no significant differences at any time point between groups.
  
  
  CONCLUSIONS
  The fluid lavage of open wounds pilot randomized controlled trial demonstrated the possibility that the use of low pressure may decrease the reoperation rate for infection, wound healing problems, or nonunion. We have demonstrated the desirability and feasibility of a definitive trial examining the effects of alternative irrigation approaches.
authors.affiliation: McMaster University, Hamilton, Ontario, Canada.
authors.forename: Bradley
authors.initials: B
authors.lastname: Petrisor
authors.forename: Xin
authors.initials: X
authors.lastname: Sun
authors.forename: Mohit
authors.initials: M
authors.lastname: Bhandari
authors.forename: Gordon
authors.initials: G
authors.lastname: Guyatt
authors.forename: Kyle J
authors.initials: KJ
authors.lastname: Jeray
authors.forename: Sheila
authors.initials: S
authors.lastname: Sprague
authors.forename: Stephanie
authors.initials: S
authors.lastname: Tanner
authors.forename: Emil
authors.initials: E
authors.lastname: Schemitsch
authors.forename: Parag
authors.initials: P
authors.lastname: Sancheti
authors.forename: Jeff
authors.initials: J
authors.lastname: Anglen
authors.forename: Paul
authors.initials: P
authors.lastname: Tornetta
authors.forename: Michael
authors.initials: M
authors.lastname: Bosse
authors.forename: Susan
authors.initials: S
authors.lastname: Liew
authors.forename: Stephen
authors.initials: S
authors.lastname: Walter
mesh_terms: D000328:Adult; D015331:Cohort Studies; D004311:Double-Blind Method; D005240:Feasibility Studies; D005260:Female; D017102:Fracture Healing; D005597:Fractures, Open / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012086:Reoperation; D012915:Soaps / Q000008:administration & dosage*; D007507:Therapeutic Irrigation; D016896:Treatment Outcome
chemical_list: D012915:Soaps